(175 days)
No
The device description and performance studies focus on the material properties and physical characteristics of a surgical mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the reinforcement of tissues during surgical repair and reconstruction of hernias and soft tissue deficiencies, which aligns with the definition of a therapeutic device.
No
The device is a surgical mesh used for tissue reinforcement, reconstruction, and bridging defects, which are therapeutic rather than diagnostic purposes.
No
The device description clearly states it is a physical surgical mesh made of polypropylene and silicone, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of tissues during surgical repair" and "reconstruction of hernias and soft tissue deficiencies." This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details a surgical mesh made of synthetic materials designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
The SURGIMESH®XB - Skirted mesh is used for the reinforcement of tissues during surgical repair.
The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
Product codes
FTL, OXJ
Device Description
The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.
More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Preclinical testing was conducted. Biocompatibility, product structure, and final product specifications were all tested. In all instances, the SURGIMESH®XB -Skirted functioned as intended and the results observed were as expected. Specifically, the company conducted the following performance testing:
- Biocompatibility testing in accordance with ISO 10993-1 standards were conducted and results demonstrated that the device is biocompatible per these standards;
- Sterilization validation testing in accordance with ISO 10993-7, ISO . 11137-1, ISO 14937, and USP 28 and results demonstrated that the device is sterile per these standards;
- Product packaging testing in accordance with ISO 11607 and results . demonstrated that the device packaging has the appropriate sealing characteristics:
- The device structure and product characterization testing was performed in accordance with ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1 and ISO 13938-1 and results demonstrated the SURGIMESH®XB - Skirted specifications are substantially similar to the identified predicate device specifications.
Key Metrics
Not Found
Predicate Device(s)
K072974, K061445, K992189, K110816
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
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K120025 page 1/3
Image /page/0/Picture/22 description: The image shows the logo for Aspide Medical. The word "ASPIDE" is in a large, bold font, with the word "Medical" in a smaller font underneath. Above the word "ASPIDE" is a graphic of a grid of squares.
PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XB - SKIRTED
510(k) Summary
JUN 2 6 2012
SURGIMESH®XB - Skirted
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ASPIDE MEDICAL 246 allée Lavoisier 42350 LA TALAUDIERE (FRANCE) Tel: +33 4 77 53 16 59 Fax: +33 4 77 53 01 97
Contact Person; Mr, William Wiecek
Date Prepared: May 4, 2012
Name of Device and Name/Address of Sponsor
SURGIMESH®XB - Skirted
ASPIDE MEDICAL 246 allée Lavoisier 42350 LA TALAUDIERE (FRANCE)
Common or Usual Name
Polymeric Surgical Mesh
Classification Name
Surgical Mesh
Predicate Devices
(1) Apide Medical's SURGIMESH®XB (K072974); (2) Aspide Medical's SURGIMESH®WN (K061445); (3) Gore's DUALMESH (K992189); and (4) Covidien's PARIETEX COMPOSITE OPEN ("PCO") SKIRT Mesh (K110816).
Intended Use / Indications for Use
The SURGIMESH® XB - Skirted mesh is used for the reinforcement of tissues during surgical repair.
The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
1
K120025 Page 2/3
Image /page/1/Picture/1 description: The image contains a logo with the word "ASPIDE" in a bold, sans-serif font, with the word underlined. Below "ASPIDE" is the word "Médical" in a smaller, italicized font. Above the word "ASPIDE" is a graphic consisting of a series of small, filled squares arranged in a diagonal line, creating a visual element above the text.
PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XB - SKIRTED
Technological Characteristics
The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.
More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).
Performance Data
Preclinical testing was conducted. Biocompatibility, product structure, and final product specifications were all tested. In all instances, the SURGIMESH®XB -Skirted functioned as intended and the results observed were as expected. Specifically, the company conducted the following performance testing:
- Biocompatibility testing in accordance with ISO 10993-1 standards ● were conducted and results demonstrated that the device is biocompatible per these standards;
- Sterilization validation testing in accordance with ISO 10993-7, ISO . 11137-1, ISO 14937, and USP 28 and results demonstrated that the device is sterile per these standards;
- Product packaging testing in accordance with ISO 11607 and results . demonstrated that the device packaging has the appropriate sealing characteristics:
- The device structure and product characterization testing was . performed in accordance with ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1 and ISO 13938-1 and results demonstrated the SURGIMESH®XB - Skirted specifications are substantially similar to the identified predicate device specifications.
Substantial Equivalence
The SURGIMESH®XB - Skirted is substantially equivalent to: (1) Apide Medical's SURGIMESH®XB (K072974); (2) Aspide Medical's SURGIMESH®WN (K061445); (3) Gore's DUALMESH (K992189); and (4) Covidien's PARIETEX COMPOSITE OPEN ("PCO") SKIRT Mesh (K110816).
The SURGIMESH®XB - Skirted has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the SURGIMESH®XB - Skirted and its
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K120025 page 3/3
Image /page/2/Picture/1 description: The image shows the logo for "ASPIDE Médical". The word "ASPIDE" is in a bold, sans-serif font, and there is a line underneath it. Below "ASPIDE" is the word "Médical" in a smaller font. Above the word "ASPIDE" is a graphic of a square made up of smaller squares.
PREMARKET NOTIFICATION 510(k) SURGICAL MESH: SURGIMESH®XB - SKIRTED
predicate devices raise no new issues of safety or effectiveness. The SURGIMESH®XB - Skirted mesh's mechanical and material characteristics are substantially equivalent to its predicate devices. Thus, the SURGIMESH®XB -Skirted is substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUN 2 6 2012
Aspide Medical % Mr. John J. Smith Partner, Hogan Lovells US LLP 555 Thirteenth St, NW Columbia Square Washington, District of Columbia 20004-1109
Re: K120025
Trade/Device Name: SURGIMESH®XB-Skirted mesh Regulation Number: CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: June 19, 2012 Received: June 19, 2012
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. John J. Smith
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric L. Keith
£ / Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
120025
510(k) Number (if known):
Device Name: SURGIMESH®XB - Skirted mesh
Indications for Use:
The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.
The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera
Prescription Use X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krane for UMM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120025